Coiled anchor device

ABSTRACT

A coiled anchor that secures to a connector as part of an anchor assembly is disclosed. The coiled anchor includes windings which capture and deform the connector between the windings and prevent the connector from disengaging from the coiled anchor once engaged.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of: 1) copending U.S. patentapplication Ser. No. 12/852,243, filed Aug. 6, 2010; 2) copending U.S.patent application Ser. No. 12/512,674, filed Jul. 30, 2009 which claimsthe benefit of Provisional Application Ser. No. 61/084,937; 3) copendingU.S. patent application Ser. No. 11/775,162, filed Jul. 9, 2007: 4)copending U.S. patent application Ser. No. 11/671,914, filed Feb. 6,2007; 5) copending U.S. patent application Ser. No. 11/492,690, filed onJul. 24, 2006; 6) copending U.S. patent application Ser. No. 11/833,660,filed on Aug. 3, 2007, which is a continuation of U.S. patentapplication Ser. No. 11/318,246, filed on Dec. 20, 2005; and 7)copending U.S. patent application Ser. No. 11/838,036 filed on Aug. 13,2007, which is a continuation of U.S. patent application Ser. No.11/134,870 filed on May 20, 2005; the entire disclosures of each ofwhich are expressly incorporated herein by reference.

FIELD OF THE INVENTION

The disclosed embodiments relate generally to medical devices andmethods, and more particularly to systems and associated methods formanipulating or retracting tissues and anatomical or other structureswithin the body of human or animal subjects for the purpose of treatingdiseases or disorders.

BACKGROUND

There are a wide variety of situations in which it is desirable to lift,compress or otherwise reposition normal or aberrant tissues oranatomical structures (e.g., glands, organs, ligaments, tendons,muscles, tumors, cysts, fat pads, and the like) within the body of ahuman or animal subject. Such procedures are often carried out for thepurpose of treating or palliating the effects of diseases or disorders(e.g., hyperplasic conditions, hypertrophic conditions, neoplasias,prolapses, herniations, stenoses, constrictions, compressions,transpositions, congenital malformations, and the like) and/or forcosmetic purposes (e.g., face lifts, breast lifts, brow lifts, and thelike) and/or for research and development purposes (e.g., to createanimal models that mimic various pathological conditions). In many ofthese procedures, surgical incisions are made in the body, and laborioussurgical dissection is performed to access and expose the affectedtissues or anatomical structures. Thereafter, in some cases, theaffected tissues or anatomical structures are removed or excised. Inother cases, various natural or man-made materials are used to lift,sling, reposition or compress the affected tissues.

Benign Prostatic Hyperplasia (BPH):

One example of a condition where it is desirable to lift, compress orotherwise remove a pathologically enlarged tissue is Benign ProstaticHyperplasia (BPH). BPH is one of the most common medical conditions thataffects men, especially elderly men. It has been reported that, in theUnited States, more than half of all men have histopathologic evidenceof BPH by age 60 and, by age 85, approximately 9 out of 10 men sufferfrom the condition. Moreover, the incidence and prevalence of BPH isexpected to increase as the average age of the population increases indeveloped countries.

The prostate gland enlarges throughout a man's life. In some men, theprostatic capsule around the prostate gland may prevent the prostategland from enlarging further. This causes the inner region of theprostate gland to squeeze the urethra. This pressure on the urethraincreases resistance to urine flow through the region of the urethraenclosed by the prostate. Thus, the urinary bladder has to exert morepressure to force urine through the increased resistance of the urethra.Chronic over-exertion causes the muscular walls of the urinary bladderto remodel and become stiffer. This combination of increased urethralresistance to urine flow and stiffness and hypertrophy of urinarybladder walls leads to a variety of lower urinary tract symptoms (LUTS)that may severely reduce the patient's quality of life. These symptomsinclude weak or intermittent urine flow while urinating, straining whenurinating, hesitation before urine flow starts, feeling that the bladderhas not emptied completely even after urination, dribbling at the end ofurination or leakage afterward, increased frequency of urinationparticularly at night, urgent need to urinate, and the like.

In addition to patients with BPH, LUTS may also be present in patientswith prostate cancer, prostate infections, and chronic use of certainmedications (e.g. ephedrine, pseudoephedrine, phenylpropanolamine,antihistamines such as diphenhydramine, chlorpheniramine, and the like)that cause urinary retention especially in men with prostateenlargement.

Although BPH is rarely life threatening, it can lead to numerousclinical conditions including urinary retention, renal insufficiency,recurrent urinary tract infection, incontinence, hematuria, and bladderstones.

In developed countries, a large percentage of the patient populationundergoes treatment for BPH symptoms. It has been estimated that by theage of 80 years, approximately 25% of the male population of the UnitedStates will have undergone some form of BPH treatment. At present, theavailable treatment options for BPH include watchful waiting,medications (phytotherapy and prescription medications), surgery andminimally invasive procedures.

For patients who choose the watchful waiting option, no immediatetreatment is provided to the patient, but the patient undergoes regularexams to monitor progression of the disease. This is usually done onpatients that have minimal symptoms that are not especially bothersome.

Medications for treating BPH symptoms include phytotherapy andprescription medications. In phytotherapy, plant products such as SawPalmetto, African Pygeum, Serenoa Repens (sago palm) and South Africanstar grass are administered to the patient. Prescription medications areprescribed as first line therapy in patients with symptoms that areinterfering with their daily activities. Two main classes ofprescription medications are alpha-1 a-adrenergic receptors blockers and5-alpha-reductase inhibitors. Alpha-1 a-adrenergic receptors blockersblock the activity of alpha-1 a-adrenergic receptors that areresponsible for causing constriction of smooth muscle cells in theprostate. Thus, blocking the activity of alpha-1 a-adrenergic receptorscauses prostatic smooth muscle relaxation. This, in turn, reducesurethral resistance thereby reducing the severity of the symptoms.5-alpha-reductase inhibitors block the conversion of testosterone todi-hydro-testosterone. Di-hydro-testosterone causes growth of epithelialcells in the prostate gland. Thus, 5-alpha-reductase inhibitors causeregression of epithelial cells in the prostate gland and, hence, reducethe volume of the prostate gland, which in turn reduces the severity ofthe symptoms.

Surgical procedures for treating BPH symptoms include TransurethralResection of Prostate (TURP), Transurethral Electrovaporization ofProstate (TVP), Transurethral Incision of the Prostate (TUIP), LaserProstatectomy and Open Prostatectomy.

Transurethral Resection of Prostate (TURP) is the most commonlypracticed surgical procedure implemented for the treatment of BPH. Inthis procedure, prostatic urethral obstruction is reduced by removingmost of the prostatic urethra and a sizeable volume of the surroundingprostate gland. This is carried out under general or spinal anesthesia.In this procedure, a urologist visualizes the urethra by inserting aresectoscope, that houses an optical lens in communication with a videocamera, into the urethra such that the distal region of the resectoscopeis in the region of the urethra surrounded by the prostate gland. Thedistal region of the resectoscope consists of an electric cutting loopthat can cut prostatic tissue when an electric current is applied to thedevice. An electric return pad is placed on the patient to close thecutting circuit. The electric cutting loop is used to scrape away tissuefrom the inside of the prostate gland. The tissue that is scraped awayis flushed out of the urinary system using an irrigation fluid. Using acoagulation energy setting, the loop is also used to cauterizetransected vessels during the operation.

Another example of a surgical procedure for treating BPH symptoms isTransurethral Electrovaporization of the Prostate (TVP). In thisprocedure, a part of prostatic tissue squeezing the urethra isdesiccated or vaporized. This is carried out under general or spinalanesthesia. In this procedure, a resectoscope is insertedtransurethrally such that the distal region of the resectoscope is inthe region of the urethra surrounded by the prostate gland. The distalregion of the resectoscope consists of a rollerball or a grooved rollerelectrode. A controlled amount of electric current is passed through theelectrode. The surrounding tissue is rapidly heated up and vaporized tocreate a vaporized space. Thus, the region of the urethra that isblocked by the surrounding prostate gland is opened up.

Another example of a surgical procedure for treating BPH symptoms isTransurethral Incision of the Prostate (TUIP). In this procedure, theresistance to urine flow is reduced by making one or more incisions inthe prostate gland in the region where the urethra meets the urinarybladder. This procedure is performed under general or spinal anesthesia.In this procedure, one or more incisions are made in the muscle of thebladder neck, which is the region where the urethra meets the urinarybladder. The incisions are in most cases deep enough to cut thesurrounding prostate gland tissue including the prostatic capsule. Thisreleases any compression on the bladder neck and causes the bladder neckto spring apart. The incisions can be made using a resectoscope, laserbeam, and the like.

Another example of a surgical procedure for treating BPH symptoms isLaser Prostatectomy. Two common techniques used for Laser Prostatectomyare Visual Laser Ablation of the Prostate (VLAP) and the Holmium LaserResection/Enucleation of the Prostate (HoLEP). In VLAP, a neodymium:Yttrium-aluminum-gamet (NdYAG) laser is used to ablate tissue by causingcoagulation necrosis. The procedure is performed under visual guidance.In HoLEP, a holmium: Yttrium-aluminum-gamet laser is used for directcontact ablation of tissue. Both these techniques are used to removetissue obstructing the urethral passage to reduce the severity of BPHsymptoms.

Another example of a surgical procedure for treating BPH symptoms isPhotoselective Vaporization of the Prostate (PVP). In this procedure,laser energy is used to vaporize prostatic tissue to relieve obstructionto urine flow in the urethra. The type of laser used is the lithiumtriborate (LBO) laser. The wavelength of this laser is highly absorbedby oxyhemoglobin. This laser vaporizes cellular water and, hence, isused to remove tissue that is obstructing the urethra.

Another example of a surgical procedure for treating BPH symptoms isOpen Prostatectomy. In this procedure, the prostate gland is surgicallyremoved by an open surgery. This is done under general anesthesia. Theprostate gland is removed through an incision in the lower abdomen orthe perineum. The procedure is used mostly in patients that have a large(greater than approximately 100 grams) prostate gland.

Minimally invasive procedures for treating BPH symptoms includeTransurethral Microwave Thermotherapy (TUMT), Transurethral NeedleAblation (TUNA), Interstitial Laser Coagulation (ILC), and ProstaticStents.

In Transurethral Microwave Thermotherapy (TUMT), microwave energy isused to generate heat that destroys hyperplastic prostate tissue. Thisprocedure is performed under local anesthesia. In this procedure, amicrowave antenna is inserted in the urethra. A rectal thermosensingunit is inserted into the rectum to measure rectal temperature. Rectaltemperature measurements are used to prevent overheating of theanatomical region. The microwave antenna is then used to delivermicrowaves to lateral lobes of the prostate gland. The microwaves areabsorbed as they pass through prostate tissue. This generates heat whichin turn destroys the prostate tissue. The destruction of prostate tissuereduces the degree of squeezing of the urethra by the prostate gland,thus, reducing the severity of BPH symptoms.

Another example of a minimally invasive procedure for treating BPHsymptoms is Transurethral Needle Ablation (TUNA). In this procedure,heat-induced coagulation necrosis of prostate tissue regions causes theprostate gland to shrink. It is performed using local anesthetic andintravenous or oral sedation. In this procedure, a delivery catheter isinserted into the urethra. The delivery catheter comprises tworadiofrequency needles that emerge at an angle of 90 degrees from thedelivery catheter. The two radiofrequency needles are aligned at anangle of 40 degrees to each other so that they penetrate the laterallobes of the prostate. A radiofrequency current is delivered through theradiofrequency needles to heat the tissue of the lateral lobes to 70-100degree Celsius at a radiofrequency power of approximately 456 KHz forapproximately 4 minutes per lesion. This creates coagulation defects inthe lateral lobes. The coagulation defects cause shrinkage of prostatictissue which in turn reduces the degree of squeezing of the urethra bythe prostate gland thus reducing the severity of BPH symptoms.

Another example of a minimally invasive procedure for treating BPHsymptoms is Interstitial Laser Coagulation (ILC). In this procedure,laser-induced necrosis of prostate tissue regions causes the prostategland to shrink. It is performed using regional anesthesia, spinal orepidural anesthesia or local anesthesia (periprostatic block). In thisprocedure, a cystoscope sheath is inserted into the urethra, and theregion of the urethra surrounded by the prostate gland is inspected. Alaser fiber is inserted into the urethra. The laser fiber has a sharpdistal tip to facilitate the penetration of the laser scope intoprostatic tissue. The distal tip of the laser fiber has adistal-diffusing region that distributes laser energy 360° along theterminal 3 mm of the laser fiber. The distal tip is inserted into themiddle lobe of the prostate gland, and laser energy is delivered throughthe distal tip for a desired time. This heats the middle lobe and causeslaser-induced necrosis of the tissue around the distal tip. Thereafter,the distal tip is withdrawn from the middle lobe. The same procedure ofinserting the distal tip into a lobe and delivering laser energy isrepeated with the lateral lobes. This causes tissue necrosis in severalregions of the prostate gland which, in turn, causes the prostate glandto shrink. Shrinkage of the prostate gland reduces the degree ofsqueezing of the urethra by the prostate, thus, reducing the severity ofBPH symptoms.

Another example of a minimally invasive procedure for treating BPHsymptoms is implanting Prostatic Stents. In this procedure, the regionof urethra surrounded by the prostate is mechanically supported toreduce the constriction caused by an enlarged prostate. Prostatic stentsare flexible devices that are expanded after their insertion in theurethra. They mechanically support the urethra by pushing theobstructing prostatic tissue away from the urethra. This reduces theconstriction of the urethra and improves urine flow past the prostategland thereby reducing the severity of BPH symptoms.

Although existing treatments provide some relief to the patient fromsymptoms of BPH, they have disadvantages. Alpha-1 a-adrenergic receptorsblockers have side effects such as dizziness, postural hypotension,lightheadedness, asthenia and nasal stuffiness. Retrograde ejaculationcan also occur. 5-alpha-reductase inhibitors have minimal side effects,but only have a modest effect on BPH symptoms and the flow rate ofurine. In addition, anti-androgens, such as 5-alpha-reductase, requiremonths of therapy before LUTS improvements are observed. Surgicaltreatments of BPH carry a risk of complications including erectiledysfunction; retrograde ejaculation; urinary incontinence; complicationsrelated to anesthesia; damage to the penis or urethra; need for a repeatsurgery; and the like. Even TURP, which is the gold standard intreatment of BPH, carries a high risk of complications. Adverse eventsassociated with this procedure are reported to include retrogradeejaculation (65% of patients), post-operative irritation (15%), erectiledysfunction (10%), need for transfusion (8%), bladder neck constriction(7%), infection (6%), significant hematuria (6%), acute urinaryretention (5%), need for secondary procedure (5%), and incontinence(3%). Typical recovery from TURP involves several days of inpatienthospital treatment with an indwelling urethral catheter, followed byseveral weeks in which obstructive symptoms are relieved, but there ispain or discomfort during micturition.

The reduction in the symptom score after minimally invasive proceduresis not as large as the reduction in symptom score after TURP. Up to 25%of patients who receive these minimally invasive procedures ultimatelyundergo a TURP within 2 years. The improvement in the symptom scoregenerally does not occur immediately after the procedure. For example,it takes an average of one month for a patient to notice improvement insymptoms after TUMT and 1.5 months to notice improvement after ILC. Infact, symptoms are typically worse for these therapies that heat or cooktissue, because of the swelling and necrosis that occurs in the initialweeks following the procedures. Prostatic stents often offer moreimmediate relief from obstruction but are now rarely used because ofhigh adverse effect rates. Stents have the risk of migration from theoriginal implant site (up to 12.5% of patients), encrustation (up to27.5%), incontinence (up to 3%), and recurrent pain and discomfort. Inpublished studies, these adverse effects necessitated 8% to 47% ofstents to be explanted. Overgrowth of tissue through the stent andcomplex stent geometries has made their removal quite difficult andinvasive.

Thus, the most effective current methods of treating BPH carry a highrisk of adverse effects. These methods and devices either requiregeneral or spinal anesthesia or have potential adverse effects thatdictate that the procedures be performed in a surgical operating room,followed by a hospital stay for the patient. The methods of treating BPHthat carry a lower risk of adverse effects are also associated with alower reduction in the symptom score. While several of these procedurescan be conducted with local analgesia in an office setting, the patientdoes not experience immediate relief and, in fact, often experiencesworse symptoms for weeks after the procedure until the body begins toheal. Additionally, all device approaches require a urethral catheterplaced in the bladder, and in some cases for weeks. In some cases,catheterization is indicated because the therapy actually causesobstruction during a period of time post operatively, and in other casesit is indicated because of post-operative bleeding and potentiallyocclusive clot formation. While drug therapies are easy to administer,the results are suboptimal, take significant time to take effect, andoften entail undesired side effects.

Cosmetic or Reconstructive Tissue Lifting and Repositioning:

Many cosmetic or reconstructive surgical procedures involve lifting,compressing or repositioning of natural tissue, natural tissue orartificial grafts, or aberrant tissue. For example, surgical proceduressuch as face lifts, brow lifts, neck lifts, tummy tucks, and the like,have become commonplace. In many cases, these procedures are performedby creating incisions through the skin, dissecting to a plane beneathmuscles and fascia, freeing the muscles, fascia and overlying skin fromunderlying structures (e.g., bone or other muscles), lifting orrepositioning the freed muscles, fascia and overlying skin, and thenattaching the repositioned tissues to underlying or nearby structures(e.g., bone, periostium, or other muscles) to hold the repositionedtissues in their new (e.g., lifted) position. In some cases, excess skinmay also be removed during the procedure.

There have been attempts to develop minimally invasive devices andmethods for cosmetic lifting and repositioning of tissues. For example,connector suspension lifts have been developed where one end of astandard or modified connector thread is attached to muscle and theother end is anchored to bone, periostium or another structure to liftand reposition the tissues as desired. Some of these connectorsuspension techniques have been performed through cannulas or needlesinserted though relatively small incisions of puncture wounds.

There remains a need for the development of a suture lock or sutureanchor that can be used throughout the body. The disclosed embodimentsaddress these and other needs.

SUMMARY

Briefly and in general terms, the disclosed embodiments are directedtowards anchor assemblies for positioning within a patient's body. Inone particular aspect, the disclosed embodiments are directed towards ananchor assembly, which includes a first or distal anchor assemblycomponent that is deployed at a first location within a patient's body,and a second or proximal anchor assembly component that is deployed at asecond location within the patient. The device also accomplishesimparting a tension between implanted anchor components.

In one aspect, the second or proximal anchor assembly component includesa coiled portion intended to receive and lock onto a connector. Thecoiled portion can extend an entire or a portion of a length of thesecond anchor. Moreover, the second anchor can have a pitch that variesalong its length and can include a pitch that decreases from a first endto a midsection. The second anchor can further include first and secondoverlapping coiled portions, the termination of one coiled portiondefining a space for receiving the connector. Further, the second anchorcan include a tubular portion connected to a coiled portion, the tubularand coiled portions defining a longitudinal bore for receiving aconnector. In other contemplated approaches, coiled structures cooperatewith additional subassemblies to define the anchor.

Furthermore, in one embodiment the anchor assembly includes a distalanchor for securing to a suture connector as part of a distal end of theanchor system. The distal anchor includes a generally tubular headportion, a mid-section transitioning from the head portion, and a tailportion, wherein the tail portion is connected to the mid-section via aconnector section. The connector section acts as a spring to create arelative unconstrained laterally oriented configuration between the headportion and the tail portion. The tail portion embodies structure havinga surface area that is larger than the connector section to provide asubstantial platform for engaging tissue at a target site. In oneparticular approach, a body of the distal anchor includes a coiledportion extending from which is a tail.

Other features and advantages will become apparent from the followingdetailed description, taken in conjunction with the accompanyingdrawings, which illustrate by way of example, the features of thevarious embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-B are perspective views of one embodiment of an anchor assemblythat includes a distal anchor and a proximal anchor secured together bya suture and a delivery device for assembling the anchor assembly;

FIG. 2 is an enlarged view of the coiled anchor shown in FIG. 1;

FIG. 3A is a cross section of the coiled anchor of FIG. 1;

FIG. 3B is an enlarged cross section view of a portion of the coiledanchor of FIG. 3A;

FIGS. 4A-C are perspective views of turning the coiled anchor of FIG. 1onto a connector;

FIG. 5 is a perspective view of another embodiment of a coiled anchor;

FIG. 6 is a side enlarged view of the coiled anchor of FIG. 5;

FIGS. 7A-B are side views, depicting another approach to a coiledanchor;

FIGS. 8A-C are perspective views, depicting approaches to a coiledanchor assembly;

FIGS. 9A-C are side views, depicting yet further approaches to a coiledanchor assembly;

FIGS. 10A-C are perspective views, depicting an approach to a coileddistal anchor; and

FIGS. 11A-F are partial views of a coiled anchor assembly beingimplanted through the prostate of an individual with benign prostatichyperplasia.

DETAILED DESCRIPTION

Turning now to the figures, which are provided by way of example and notlimitation, the disclosed embodiments are illustrated with regard toanchor assemblies configured to be delivered within a patient's body. Asstated, the disclosed embodiments can be employed for various medicalpurposes including but not limited to approximating, retracting,lifting, compressing, supporting or repositioning tissues, organs,anatomical structures, grafts or other material found within a patient'sbody. Such tissue manipulation is intended to facilitate the treatmentof diseases or disorders. Moreover, the disclosed embodiments haveapplications in cosmetic or reconstruction purposes, or in areasrelating to the development or research of medical treatments.

In such applications, one portion of an anchor assembly is positionedand implanted against a first section of anatomy. A second portion ofthe anchor assembly is then positioned and implanted adjacent to asecond section of anatomy for the purpose of approximating, retracting,lifting, compressing, supporting or repositioning one section of anatomywith respect to the other section of anatomy, as well as for the purposeof approximating, retracting, lifting, compressing, supporting orrepositioning one section of anatomy with respect to the other sectionof anatomy. It is also to be recognized that both a first and secondportion of the anchor assembly can be configured to accomplish thedesired approximating, retracting, lifting, compressing, supporting orrepositioning of anatomy due to tension supplied thereto via a connectorassembly (e.g., suture) affixed to the first and second portions of theanchor assembly.

In one embodiment of the anchor assembly, the anchor assembly isconfigured to include structure that is capable of being implantedwithin a patient's body. The anchor assembly may also be used inconjunction with a conventional remote viewing device (e.g., anendoscope) so that an interventional site can be observed.

In one aspect, the anchor assembly can be placed at an intervention siteusing a delivery tool. One specific, non-limiting application of thedelivery tool is for the treatment of benign prostatic hyperplasia. Inthis procedure, an implant is delivered to a prostatic lobe that isobstructing the urethral opening and restricting flow. The implantcompresses the lobe, thereby increasing the urethral opening andreducing the fluid obstruction through the prostatic urethra.

Referring now to the drawings, wherein like reference numerals denotelike or corresponding components throughout the drawings and, moreparticularly to FIGS. 1A-4C, there is shown an embodiment of an anchorassembly. Accordingly, in one embodiment, the anchor assembly 50 isembodied in a tissue approximation anchor (TAA). The tissueapproximation anchor is an implant assembly that includes one tubularmember, referred to as the capsular anchor or, more generally, distalanchor 70. The distal anchor 70 is preferably connected by a suture(preferably polyester) 78 to an urethral anchor or proximal anchor 84.In one specific, non-limiting embodiment, the distal anchor 70 iscomprised of an electro-polished Nitinol (nickel titanium alloy SE508,55.8% nickel) tube.

The tissue approximation anchor is designed to be useable in an officeenvironment (in contrast to requiring a hospital environment). Thedelivery tool is used through a 19 Fr introducer sheath size in onepreferred embodiment, while in another embodiment a sheath size of 21 Fis employed. Additionally, the material selection and construction ofthe tissue approximation anchor still allows for a subsequent TURPprocedure to be performed, if necessary. In this suture-based, tissueapproximation technique, a needle delivery mechanism is used to implanta nitinol distal anchor 70 and attached connector or suture 78. In oneapproach, the introducer sheath is first placed within a patient'surethra. An anchor housed within the delivery tool is then placedthrough the introducer sheath and a distal portion of the delivery toolis placed at the interventional site. Once the distal anchor 70 andattached suture 78 have been deployed, with the needle retracted and thesuture 78 tensioned, the anchor 84 is pushed by the delivery tool andcaptures the suture 78 transverse to the anchor axis.

In one embodiment, the nitinol tube is attached to a USP size 0 PET(Poly Ethylene Terephthalate) monofilament suture 78 by thermallyforming the suture to locking features on the anchor 70. Referring againto the suture itself, the PET suture is a round monofilamentextrusion/pulltrusion composed of a grade 8816 polyethyleneterephthalate. Typically, the base material for the suture is annealedat approximately 191 degrees Celsius for approximately 5 minutes in astraight condition. In one non-limiting embodiment, the PET suture 78has a diameter of 0.015 inches and a tensile strength greater than orequal to 6.0 pounds.

The proximal anchor 84 can embody a flat stainless steel wound coil(0.0086 inches×0.0155 inches) with a 0.040 inch outer diameter. One endportion 86 of the anchor 84 can have an elongated pitch that decreasesalong a length of the anchor toward its mid-section 88. The mid-section88 can include coils intended to lockingly grasp the connector 78.

Thus, as best seen in FIG. 2, the proximal anchor 84 can embody a twopitch or a progressive pitch coil having a greater pitch at a first end86. The greater pitch facilitates feeding a connector 78 between windsuntil the connector 78 is fixed between adjacent coils (See FIGS. 4A-C).In one approach, a reduced pitch section of the anchor 84 compresses andlocks the connector 78 midway 88 in the anchor 84.

It is contemplated that a rotational actuation 90 can be employed toattach a proximal anchor 84 to a connector 78 (See FIG. 1B). Theactuator 90 can include a slot 92 for registering the anchor 84 and totorque the anchor 84 along the connector (FIGS. 4A-C). A fixed internalor external comb (not shown) guides the coils of the anchor forward asthe device is rotated much like a bolt in a nut. The relativepositioning of the actuator 90 and anchor 84 are arranged such that theanchor 84 should fully seat and firmly attach to a connector 78 beforethe anchor 84 is released from the actuator 90. Once thisjuxtapositional relationship is achieved, the anchor 84 is immediatelyreleased from the actuator 90.

With specific reference now to FIGS. 3A-B, one cross-sectional profileof the coils of a proximal anchor is depicted. A flat wire or shapedwire is contemplated to increase line contact and increase pressure on aconnector to which the anchor 84 is affixed. Thus, the anchor 84presents a biting edge which resists a pull-off force which may beapplied to the connector.

Turning now to FIGS. 5 and 6, there is shown an alternative approach toa coiled anchor 100. Here, the anchor 100 defines a self locking coilstructure embodying a folded-over wire. The anchor is formed by bifilarwinding two wires over a mandrel to create a closed pitch coil withfirst 102 and second 104 wire ends terminating at unique points alongthe anchor 100. That is, one end 104 may terminate at a distal end 106of the anchor 100 and another end 102 terminating midway 108 along thelength of the device. The middle wire termination 108 may be bent in adirection that would allow a connector 78 to be engaged by the coil andtorqued to the middle point 108 of the anchor 100. The connector 78would thus pass across the middle wire termination 102. The orientationof the middle wire termination 102 would, in turn, prevent the connector78 from winding back out of the anchor structure.

Yet another contemplated approach to a coiled anchor 120 is shown inFIGS. 7A-B. The coiled anchor 120 can be placed in a coaxial arrangementwith a connector 78. The coiled anchor 120 is first placed on aconnector in a condition where adjacent coils are displacedlongitudinally (FIG. 7A). The adjacent coils are then permitted tocollapse longitudinally to thereby fixedly capture the connector 78.

In one contemplated embodiment, the coiled anchor 120 can have aproximal coiled portion 122 connected to a distal tubular section 124.The proximal coiled portion 122 can define a pigtail configuration thatwhen longitudinally expanded, permits the sliding of the anchor 120along a connector 78. The distal tubular section 122 includes aninternal bore which also slidingly receives the connector. Uponapproximation of tissue, the pigtail structure is permitted to contractand thereby bite into and lock with connector material and define aclosed coil structure.

A coil and slug approach 140 to a proximal anchor can also be employedin a tissue approximation interventional procedure. In this embodiment,a slug 142 having a longitudinal slot 144 sized to accept and lock ontoa connector is contemplated to be placed within a bore defined by acoiled outer member 146. The plug 142 can be positioned within a distalopening 148 to the internal bore of the coiled outer member 146 (SeeFIG. 8A) and configured to receive the connector 78 within its slottedstructure 144. As the coiled outer member 146 is threaded along theconnector 78 the slug is turned and translated further within theinternal bore of the coiled outer member 146. Upon reaching a midsectionof the assembly, the connector 78 is locked in placed as describedabove.

The coil and slug approach 140 is intended to address urine retentionwhen the assembly is used in a prostate interventional procedure. Thatis, urine retention can be reduced from the open coiled structure byfilling the void with the plug. In addition to filling the void, it iscontemplated that the slot 144 formed in the slug 142 can assume aprofile enveloping connector material. Further, the slot can extendapproximately half the length of the slug to define arms adapted toconveniently receive the connector.

In yet another embodiment (See FIGS. 9A-C), the proximal anchor 160 canembody a flat cut elongated substruction 162 configured to receive first164 and second 166 coils. The first and second coils 164, 166 areconfigured about first 168 and second 170 arms of the substructure 162such that the coils extend both distally and proximally of a midpoint ofthe substructure 162. At proximal and distal ends of the substructure162 are paddles 172 which function to limit central portions of thecoils which can in certain applications define overlapping structure.The portions of the coils 164, 166 extending along the substructure 162can be unique or symmetrical. Further, the coils 164, 166 can be pre-cutor shaped to a tissue-friendly load distributing 2D-shape. A distalpaddle 172 can be configured to extend past the connector 78 and theassembly 160 can be rotated until the connector 78 is engaged andcaptured within the coil windings. In this way, the connector 78 wouldbe locked in a transverse orientation to the anchor 160.

One alternative approach to a distal anchor 200 is depicted in FIGS.10A-C. In this embodiment, the anchor 200 includes both a body 202 and atail 204 formed by a wire. The structures can be polymer coated or canfurther include an overmolded element which increases rigidity oflocking coils together. It is also contemplated that the connector canfurther be configured as part of the overmolded element. The body 202 isdefined by a coiled section of the wire and the tail is defined by alooped section of the wire. The body 202 thus has a spring-likelongitudinal resiliency and can be sized to fixedly engage a connector.As shown, the body 202 can define coils having a variable pitch. Thetail 204 is generally curved longitudinally to facilitate anchoringfunctioning of the device.

Thus, in its pre-implanted form, the anchor assembly can include adistal anchor 70 (e.g., first anchor) whose initial engagement with asuture 78 is generally coaxial, and a proximal anchor 84 (e.g., secondanchor) with an initial engagement being generally perpendicular withthe suture 78.

As stated above, an introducer sheath (not shown) can first be placedwithin a patient's urethra for the purpose of facilitating access to atreatment site. The distal anchor 70 is “unsheathed” from the needledelivery mechanism once positioned for reliable deployment eliminatingpredicate distal suture. This results in an adjustable implant length.This distal anchor 70 configuration also provides increased yield andstrength.

With reference now to FIGS. 11A-F, in one particular, non-limiting usein treating a prostate, an elongate tissue access portion 404 of adelivery device 400 is placed within a urethra (UT) leading to a urinarybladder (UB) of a patient. The delivery device can be placed within anintroducer sheath previously positioned in the urethra or alternatively,the delivery device can be inserted directly within the urethra. Thepatient is positioned in lithotomy. The elongate portion 404 is advancedwithin the patient until a leading end 410 thereof reaches a prostategland (PG). In a specific approach, the side(s) (i.e., lobe(s)) of theprostate to be treated is chosen while the device extends through thebladder and the device is turned accordingly. The device is firstpositioned at the bladder neck and then refracted approximately 1 cmwhile keeping the device parallel to the prostatic fossa and preservingmucosa. The distal end of the elongate portion can be used to push theurethra into the prostate gland. The inside of the prostate gland (i.e.,adenoma) is spongy and compressible and the outer surface (i.e.,capsule) of the prostate gland is firm. By the physician viewing withthe endoscope, he/she can push the urethra into the prostate glandcompressing the adenoma and creating the desired opening through theurethra. To accomplish this, the physician pivots the tool laterallyabout the pubic symphysis, generally about 20 to 30 degrees (See FIG.11A). The physician then rotates the tool anterior between 9 and 10o'clock for the patient's side right lobe and between 2 and 3 o'clockfor the patient's side left lobe. Viewing through the endoscope, thephysician wants to have about the same amount of tissue protruding onboth sides of the elongate shaft (See FIG. 11B).

At the leading end 410 of the delivery device, as shown in FIG. 11C, aneedle 430 carrying an anchor assembly is ejected into and throughtissue. The needle assembly can be configured so that it curves backtoward the delivery tool as it is ejected. In use in a prostateintervention, the needle assembly 430 is advanced through and beyond aprostate gland (PG). The delivery device can be rotated anteriorly tolift a prostatic lobe.

Upon withdrawal of the needle assembly 430 (See FIG. 11D), the distalanchor 20 is left beyond the prostate (PG). Next, steps are taken toimplant the proximal anchor 84 within the urethra (FIG. 11E). Either asingle anchor assembly or multiple anchor assemblies can be deliveredand deployed at an intervention site by the deployment device (See FIG.11F). Additionally, a single anchor assembly component can for example,be placed on one side of a prostate or urethra while multiple anchorassembly components can be positioned along an opposite or displacedposition of such anatomy. The number and locations of the anchorassemblies can thus be equal and/or symmetrical, different in number andasymmetrical, or simply asymmetrically placed. In the context ofprostate treatment, the present invention is used for the compression ofthe prostate gland and the opening of the prostatic urethra, thedelivering of an implant at the interventional site, and applyingtension between ends of the implant. Moreover, drug delivery is bothcontemplated and described as a further remedy in BPH and over activebladder treatment as well as treating prostate cancer and prostatitis.

The disclosed embodiments contemplate both pushing directly on anchorportions of an anchor assembly as well as pushing directly upon theconnector of the anchor assembly. Further, an anchor assembly can bedelivered and deployed at an interventional site by a deployment device.Consequently, in the context of prostate treatment, the disclosedembodiments accomplish both compressing of the prostate gland and theopening of the prostatic urethra and applying tension between ends ofthe implant. Moreover, drug delivery is contemplated as a further remedyin BPH and over-active bladder treatment.

Once implanted, the anchor assembly of the disclosed embodimentsaccomplishes desired tissue approximation, manipulation, compression orretraction, as well as cooperates with the target anatomy to provide anatraumatic support structure. In particular, the shape and contour ofthe anchor assembly can be configured so that the assembly invaginateswithin target tissue, such as within natural folds formed in the urethraby the opening of the urethra lumen by the anchor assembly. In fact, insituations where the anchor assembly is properly placed, wispy orpillowy tissue in the area collapses around the anchor structure.Eventually, the natural tissue can grow over the anchor assembly, andnew cell growth occurs over time. Such cooperation with target tissuefacilitates healing and avoids unwanted side effects such ascalcification or infection at the interventional site.

Furthermore, in addition to an intention to cooperate with naturaltissue anatomy, the disclosed embodiments also contemplate approaches toaccelerate healing or induce scarring. Manners in which healing can bepromoted can include employing abrasive materials, textured connectors,biologics and drugs.

It has been observed that placing the anchors at various desiredpositions within the anatomy can extract the best results. For example,when treating a prostate, one portion of an anchor can be placed withina urethra. It has been found that configuring such anchors so that teno'clock and two o'clock positions (when looking along the axis of theurethra) are supported or retained, effectively holds the anatomy openand also can facilitate invagination of the anchor portion withinnatural tissue. Typically, one to two pairs of anchor assemblies areimplanted to create an anterior channel along the urethra within theprostate gland (FIG. 11F). This is particularly true in the regions ofanatomy near the bladder and the juncture at which the ejaculatory ductconnects to the urethra.

Moreover, it is to be recognized that the foregoing procedure isreversible. In one approach, the connection of an anchor assembly can besevered and a proximal (or second) anchor component removed from thepatient's body. For example, the physician can simply cut the connectorand simultaneously remove the second anchor previously implanted forexample, in the patient's urethra. It is to be recognized that variousmaterials are contemplated for manufacturing the disclosed devices.Moreover, one or more components such as distal anchor, proximal anchor,suture, of the one or more anchor assemblies disclosed herein may bedesigned to be completely or partially biodegradable orbio-fragmentable.

Further, as stated, the systems and methods disclosed herein may be usedto treat a variety of pathologies in a variety of tubular structurescomprising a cavity or a wall. Examples of such organs include, but arenot limited to urethra, bowel, stomach, esophagus, trachea, bronchii,bronchial passageways, veins (e.g. for treating varicose veins orvalvular insufficiency), arteries, lymphatic vessels, ureters, bladder,cardiac atria or ventricles, uterus, fallopian tubes, and the like.

Finally, it is to be appreciated that the invention has been describedhereabove with reference to certain examples or embodiments, but thatvarious additions, deletions, alterations and modifications may be madeto those examples and embodiments without departing from the intendedspirit and scope of the disclosed embodiments. For example, any elementor attribute of one embodiment or example may be incorporated into orused with another embodiment or example, unless to do so would renderthe embodiment or example unpatentable or unsuitable for its intendeduse. Also, for example, where the steps of a method are described orlisted in a particular order, the order of such steps may be changedunless to do so would render the method unpatentable or unsuitable forits intended use. All reasonable additions, deletions, modifications andalterations are to be considered equivalents of the described examplesand embodiments and are to be included within the scope of the followingclaims.

The various embodiments described above are provided by way ofillustration only and should not be construed to limit the disclosedembodiments. Those skilled in the art will readily recognize variousmodifications and changes that may be made to the disclosed embodimentswithout following the example embodiments and applications illustratedand described herein, and without departing from the true spirit andscope of the disclosed embodiments, which is set forth in the followingclaims.

1-18. (canceled)
 19. A method for tissue manipulation involving at leastone anchor assembly, the method comprising: deploying an implantabledistal anchor and an attached suture at a first site; deploying a coiledproximal anchor at a second site spaced from the first site, the coiledproximal anchor including coils with a varying pitch; and turning thecoiled proximal anchor onto the suture; wherein the coiled proximalanchor lockingly engages and deforms the suture.
 20. The method of claim19, further comprising assembling the coiled proximal anchor.
 21. Themethod of claim 20, wherein the coiled proximal anchor includes twoseparated and unattached coil sections.
 22. The method of claim 20,wherein assembling involves inserting a plug into the coiled proximalanchor.
 23. The method of claim 20, wherein assembling involvesconfiguring first and second coil sections on an H-shaped substructure.24. The method of claim 20, further comprising longitudinallycontracting the coiled proximal anchor to fix the coiled proximal anchorto the suture. 25-42. (canceled)